UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002335
Receipt number R000002857
Scientific Title The effect of sacral surface electrical stimulation for assisted reproductive technology
Date of disclosure of the study information 2009/08/14
Last modified on 2010/02/15 08:59:44

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Basic information

Public title

The effect of sacral surface electrical stimulation for assisted reproductive technology

Acronym

The effect of sacral surface electrical stimulation for assisted reproductive technology

Scientific Title

The effect of sacral surface electrical stimulation for assisted reproductive technology

Scientific Title:Acronym

The effect of sacral surface electrical stimulation for assisted reproductive technology

Region

Japan


Condition

Condition

Infertile women required for assisted reproductive technology

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of pregnancy rates for assisted reproductive technology

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Morphological changes of the uterus at embryo transfer

Key secondary outcomes

Pregnancy rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Sacral surface electrical stimulation

Interventions/Control_2

control

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Infertile women

Key exclusion criteria

uterine myoma, adenomyosis, hydrosalpinx,
history of ectopic pregnancy

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Murakami

Organization

Shiga university of medical science

Division name

Obsatetrics and gynecology

Zip code


Address

Tsukinowa-cho, otsu, shiga

TEL

077-548-2267

Email



Public contact

Name of contact person

1st name
Middle name
Last name Wakasa Yamaguchi

Organization

Shiga university of medical science

Division name

Obsatetrics and gynecology

Zip code


Address

Tsukinowa-cho, otsu, shiga

TEL

077-548-2267

Homepage URL


Email



Sponsor or person

Institute

Shiga university of medical science

Institute

Department

Personal name



Funding Source

Organization

Shiga university of medical science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 08 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2009 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 08 Month 14 Day

Last modified on

2010 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name